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The purpose of this study is to explore the acceptability and feasibility of weighted blankets in total knee replacement (TKR) patients. The study also aims to measure the difference in anxiety of adult orthopedic patients in need of total knee arthroplasty surgery who receive weighted blanket before and after surgery compared to those who receive a non-weighted blanket.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weighted blanket | Experimental | Participants will receive a weighted blanket in the preoperative holding room and in the Post-Anesthesia Care Unit (PACU) after surgery. |
|
| Standard of care | No Intervention | Participants will receive a non-weighted blanket in the preoperative holding room prior to and in the PACU after surgery per standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weighted Blanket | Device | 5lb weighted blanket |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time participants used weighted blanket | Outcome measure assessed via investigator-created Weighted Blanket Feasibility Question in Post-Anesthesia Care Unit (PACU). Question asks "How long would you estimate that you used the weighted blanket?" Patient-reported estimate in minutes. | PACU discharge (~1-3 hours post-surgery) |
| Number of participants who would use a weighted blanket in the future | Outcome measure via investigator-created Weighted Blanket Acceptability Question in PACU. The question asks the participant "If you were offered a weighted blanket in the future, would you choose to use it?" with choices of "yes", "no", and "unsure" and then asked to explain their choice. | PACU discharge (~1-3 hours post-surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in short Spielberger State-Trait Anxiety Inventory (SSTAI) score | The STAI-5 consists of 5 items relating to anxiety, each item is scored on a 4-point scale. Scores range from 5 to 20, with higher scores indicating more anxiety. | Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Withall, PhD, RN | Contact | 212-598-6127 | Jennifer.withall@nyulangone.org | |
| Kathleen Zavotsky, PhD, RN | Contact | 212-263-2055 | Kathleen.zavotsky@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Diana Wong, MS, RN, CPAN, ONC | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Study participants did not provide consent for data sharing beyond the study team and institutional oversight. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Change in Numeric Pain Rating Scale (NPRS) score |
Pain is assessed on the NPRS from 0 (No pain) to 10 (Severe pain). |
| Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery) |
| Richmond Agitation-Sedation Scale (RASS) score | The RASS consists of a 10-point scale.. Positive scores indicate agitation, with +4 being the most severe (combative), and negative scores indicate sedation, with -5 being the deepest level of sedation (unarousable). A score of 0 indicates the patient is alert and calm. | PACU discharge (~1-3 hours post-surgery) |
| Change in heart rate | Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery) |
| Change in blood pressure | Baseline (before blanket application), PACU discharge (~1-3 hours post-surgery) |